The effect and safety of extract of pedicel of Hovenia dulcis on alcohol metabilism and hangover improvement in human study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001626

Enrollment

Registered

2015-09-16

Start date

2015-08-20

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Dietary Supplement) : Subjects were randomly allocated at placebo group, experiment groups (Hovenia dulcis fruit extract) for 12 weeks. They take placebo or hovenia dulcis fruit extract (6 tabl

s crossover designs.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) The particioants who give informed consent before the start 2) 20~40 years old, healthy male 3) BMI 18-25 kg/m2 4) Men who have a experience of hang over after drinking alcohol 5) Men with ALDH2 heterozygote

Exclusion criteria

Exclusion criteria: 1) Subject who drunk alcohol severely within 7 days prior to the first visit 2) Subject who has alcohol use disorder or alcohol intoxication 3) Subject who consumed the functional food within 4 weeks prior to the first visit 4) Subject who takes drugs such as : has a effect on alcohol metabolism, have a risk of hematemesis such as aspirin, Nonsteroidal anti-inflammatory drug (NSAID), analgesic 5) Subject with diabetes mellitus, hypertension, renal dysfunction, hepatic dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2.5 times the upper limit of normal), pancreatitis, gout, cardiovascular disease, lung disease, gastrointestinal (GI) tract dysfunction, gastrointestinal bleeding, history of GI tract surgery, Neurologic Disorder, Tuberculosis or mental disease 6) hypersensitivity for alcohol or test materials 7) Subject who has participated in another investigational study within 4 weeks prior to the first visit 8) Any condition that the principal investigator believes may put the subjects at undue risk

Design outcomes

Primary

Measure	Time frame
symtom of hang over;metabolism of alcohol biomarkers;Comparison of time point (endotoxin, Lipopolysaccharide Binding Protein, CD14(cluster of differentiation 14))	—

Secondary

Measure	Time frame
Others (endotoxin, Lipopolysaccharide Binding Protein, CD14(cluster of differentiation 14))	—

Countries

Korea, Republic of

Contacts

Public Contactmin young Park

Ewha Womans University

hanabi_223@hanmail.net+82-2-3277-3087

Outcome results